Euro pharma initiative “setting new standards”

The European Union/pharma industry Innovative Medicines Initiative (IMI) is setting new standards for sharing collaborative research and intellectual property (IP), allowing problems to be addressed which no individual company or institute can tackle alone, industry leaders said this week.

The Initiative is, uniquely, providing access to world-class research consortia across Europe, enabling those consortia to access new technologies, tools and knowledge, and establishing models for collaborative research that will be critical for future progress, Roch Doliveux, chief executive of UCB and IMI board member, told the Initiative’s annual Stakeholder Forum in Brussels this week.

Set up by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to make the drug discovery and development process in Europe more efficient and enhance the region's pharma competitiveness, the IMI is, by a wide margin, the world’s biggest public-private partnership (PPP) in the field of life sciences R&D. It supports projects which focus on unmet needs common to the pharmaceutical industry and patients - the key concepts being pre-competitive research, open innovation and patient-tailored therapies.

The Initiative is set to run to 2017 with funding of 2 billion euros, 50% of which is supplied under the Commission’s Seventh Framework Programme (FP7), the other 50% being supplied mainly “in kind” by the EFPIA and its member companies.

So far, the industry has contributed over 215 million euros to IMI projects and expects this pace of investment to continue strongly, EFPIA director general Brian Ager told the Forum, adding: “this is not about specific products, it’s about the tools which will help us all move forward.”

Every year, the IMI launches a new Call for Proposals to support biopharma research activities which are focused on safety, efficacy, knowledge management and education and training.

15 projects selected from the first Call in 2008 are now up and running, involving 395 teams and a total budget of 281 million euros. Small and medium-sized enterprises (SMEs) are “very well represented” in these projects, said Philippe Cupers of the European Commission’s Directorate General (DG) Research, who told the Forum that the benefits available to the 24 participating SMEs include opportunities for networking, deal-making and private funding, access to multicentric studies on large cohorts and international visibility.

However, he added that involvement in IMI projects can also present SMEs with problems in terms of the transfer or sharing of IP and know-how, diffusion of sensitive information and administrative burden.

But Stavros Malas, chairman of the EU States Representative Group (SRG), forecast that the IP issues should be resolved before the Third Call for Proposals, scheduled for the third quarter of this year. He welcomed the “tremendous response” to the first two calls, which together have attracted 258 expressions of interest from over 2,400 participants.

IMI executive director Michel Goldman said that experience with the Initiative so far has provided “proof of concept” evidence for this kind of PPP, and that the IMI is more than an industry/academia PPP, as evidenced by the successful involvement of SMEs, regulatory agencies and patient organisations in IMI projects. However, it has also become clear that the boundaries of pre-competitive research and IP rules can be difficult to define, he added.

During the Forum, it was announced that the “indicative” topic titles for this autumn’s Third Call for Proposals will be: safety: - assessment of drug-induced toxicity in relevant organs/surrogates for early drug failure, and - immunological safety of biopharmaceuticals; efficacy: - improving the infrastructure for tuberculosis medicines, - enhancing translation in neurological disease, and – development of personalised medicine approaches in diabetes; education and training: - fostering a broader understanding of pharmaceutical R&D in the wider public, with training programmes for the “informed patent.”